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5.0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
About RISA Labs Cancer patients face not just a disease, but a broken system where delays in treatment are common due to outdated, error-prone workflows. RISA Labs is changing that with our Business Operating System as a Service (BOSS) - a powerful platform built for the vertical complexity of healthcare, that transforms healthcare operations. Unlike simple automation tools, BOSS breaks down complex workflows into small tasks, managed by smart AI agents like LLMs, digital twins, and reinforcement learners. This creates a digital workforce that doubles the efficiency of healthcare teams, letting a 1,000-person institution operate like it has 2,000 staff overnight. Founders RISA was founded by Kshitij Jaggi and Kumar Shivang, IIT Kanpur alumni with a proven track record from their previous healthcare startup, Urban Health. Their vision is to streamline oncology care through cutting-edge technology. Funding RISA Labs is backed by $3.5 million in seed funding, led by Flipkart co-founder Binny Bansal, with support from Oncology Ventures, General Catalyst, z21 Ventures, Odd Bird VC, and angel investor Ashish Gupta. Role Overview As a Compliance Manager, you will oversee and manage the implementation, maintenance, and monitoring of RISA Labs’ compliance frameworks — including HIPAA , SOC 2 , ISO 27701 , and HiTrust . You’ll collaborate across engineering, legal, operations, and security to ensure our platform and internal practices meet industry, regulatory, and partner standards. This is a critical, cross-functional role for someone who thrives at the intersection of regulation, systems thinking, and fast-moving tech environments. Responsibilities Compliance Program Management: Own the strategy, execution, and tracking of compliance across frameworks like HIPAA, SOC 2, ISO 27701, and HiTrust Audit & Certification Readiness: Lead internal readiness efforts for audits and certifications, partnering with third-party assessors and internal stakeholders Policy Development: Draft, maintain, and implement policies, procedures, and controls aligned with regulatory and industry standards Risk Management: Conduct risk assessments, control gap analyses, and incident investigations to identify compliance weaknesses and mitigate risk Cross-Functional Collaboration: Work closely with engineering, product, security, and legal to ensure new features and systems are compliant by design Security & Privacy Oversight: Support the security team in managing vendor reviews, access controls, data handling policies, and encryption practices Employee Training & Awareness: Develop and lead internal compliance education programs, including onboarding, role-based training, and refreshers Regulatory Monitoring: Stay up to date with changes in relevant laws and standards and proactively adjust company practices to stay in alignment Reporting: Prepare reports for leadership and external stakeholders demonstrating compliance posture, audit findings, and remediation efforts Qualifications 5+ years of experience in compliance, privacy, or security-related roles, ideally within tech, SaaS, or healthcare organizations Deep understanding of HIPAA, SOC 2, ISO 27701, and HiTrust frameworks and certification processes Strong knowledge of data privacy laws (e.g., GDPR, CCPA) and IT security principles Experience working cross-functionally with product, security, legal, and engineering teams Excellent writing, policy drafting, and documentation skills High integrity and attention to detail, able to manage sensitive information and operate with discretion Bonus: Certifications such as CIPP, CISA, CISSP, or HiTrust CCSFP Bachelor’s degree in a related field (Information Security, Law, Business, or equivalent experience)
Posted 1 week ago
0 years
0 Lacs
Guntur East, Andhra Pradesh, India
On-site
Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait . We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries. For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets). ‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization. Additional Information About the Department Global Generics India Global Generics India business journey began in 1986. In the last three decades, we have grown as a trusted name in the healthcare industry and rank as one of the top 10 Pharma Companies in the Indian Pharma Market (IPM) as per IQVIA MAT (November 2022). Our commitment to Lead Ahead has helped us move ranks from 16th position to 10th position (IPM) in the last four years. We are a fast-growing organisation with double-digit growth and significant market share in domestic markets. Currently, we rank among the top 5 in oncology, anti-allergy and gastrointestinal diseases and the top 10 in a few other therapy areas. Our focus is on leveraging our digital capabilities, collaborations, innovations and inorganic opportunities to become the top 5 companies in the Indian Pharma Market. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/
Posted 1 week ago
0.0 - 8.0 years
0 Lacs
Worli, Mumbai, Maharashtra
On-site
Site Name: India - Maharashtra - Worli Mumbai Posted Date: Jul 23 2025 Job Title: Patient Support Program (PSP) Manager – Oncology Location: Mumbai Role Summary: As the PSP Manager – Oncology, you will be responsible for the seamless execution of GSK’s Patient Support Program (PSP) and Value-Added Services for oncology products. This includes overseeing patient onboarding, ensuring program compliance, enhancing patient centricity, and ensuring eligible patients gain timely access to GSK’s innovative oncology therapies. You will work closely with PSP partners, Patient Assistance Program (PAP) service vendors, and PAP distributors to ensure high-quality, compliant, and patient-focused delivery. Key Responsibilities: Program Execution & Oversight: Ensure the end-to-end implementation of the PSP in alignment with GSK policies and access strategy. Oversee the operations and deliverables of the PSP partner to ensure adherence to SLAs, timelines, and patient care standards. Patient Onboarding & Governance: Monitor patient onboarding processes to ensure robust due diligence and documentation in compliance with applicable SOPs and regulations. Conduct periodic audits and quality checks to verify eligibility, authenticity, and completeness of patient records. Vendor Management: Coordinate effectively with the PSP service provider and PAP distributor to ensure smooth supply chain and access management. Evaluate vendor performance periodically and initiate improvements where necessary. Governance & Compliance: Uphold governance standards related to data privacy, pharmacovigilance, and ethical conduct within the PSP framework. Ensure timely reporting and resolution of any discrepancies, risks, or deviations. Patient-Centric Approach: Enhance patient experience by ensuring empathetic, timely, and clear communication through the PSP. Identify and implement opportunities to improve service quality, reduce delays, and address barriers to access. Cross-functional Collaboration: Work closely with Access, Medical, Legal, Regulatory, and Commercial teams to ensure aligned execution and continuous improvement of the PSP. Qualifications & Experience: Bachelor’s degree in Life Sciences, Pharmacy, or related discipline; MBA or post-graduate qualification preferred. 5–8 years of experience in managing PSPs or access-related programs in the pharmaceutical/healthcare industry. Strong knowledge of oncology therapies and patient access challenges. Experience with vendor governance, auditing, and compliance practices. Skills & Competencies: Deep understanding of patient access models and reimbursement landscapes. High attention to detail and integrity in patient handling and documentation. Strong project management and coordination skills. Excellent stakeholder engagement and communication abilities. Ability to handle sensitive patient information with discretion and compliance. Why GSK Oncology? At GSK, we are transforming the treatment paradigm in oncology by delivering innovative, science-driven therapies to patients in need. Join us in ensuring that every eligible patient has access to life-changing innovation with empathy, integrity, and excellence. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.
Posted 1 week ago
0.0 years
0 Lacs
Mumbai, Maharashtra
On-site
At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice. Sr Medical Advisor - Oncology POSITION PURPOSE: The position is responsible for the medical and scientific support, including technical advice to the Business Units and Pharmacovigilance/ Medical Information and Clinical Research teams in their assigned therapeutic areas. The position holder oversees the Medical Affairs function in India in their assigned therapeutic/product areas and cooperates with Regional Medical Affairs functions and relevant Global Medical Affairs functions. This position holder is responsible for ensuring that marketing and sales functions have appropriate medical scientific support and training (the latter in co-operation with the Training department). To enable this support, product and development project information is to be kept up to date based on internal publications and communication with regional and global Medical Affairs functions as well as based on review of pertinent scientific publications. In addition to this, the position holder is responsible for the review process of promotional materials in the respective area according to the global SOP and local laws and compliance. The tasks also include monitoring of medical marketing activities of competitors locally and worldwide and close interaction especially with regional medical affairs functions. The position holder will further support regulatory, PV/MI and CR teams in medical scientific questions and prepare and give internal (mainly marketing and sales functions) and possibly external presentations (local advisory board meetings, launch symposia and others) to enhance the medical knowledge of development projects and marketed products. This also includes interaction and relationship-building with TLs. YOUR TASKS AND RESPONSIBILITIES : Medical Marketing Provide timely and appropriate medical review of all promotional material as well as challenging promotional activities of competitors where appropriate. Support BUs in transforming medical data into marketing strategy Work closely with other members of the medical team (especially the MSLs) to support the business Build up good relationships with customers and TLs Build strong relationships with internal customers (marketing and sales) and with regional / global Medical Affairs Provide development project and product training internally to marketing and sales functions and externally to doctors Support and educate internal customers in compliance with the Country’s Code of Conduct Provide a comprehensive and proactive Medical service that encompasses, as appropriate, including Medical Support, Medical Information and Pharmacovigilance As Senior Medical Advisor, is responsible for overall medical inputs to Integrated Brand Plans of assigned therapeutic areas, provision of scientific expertise, review of promotional materials, thought leader management, speaker development and training. Takes responsibility for study development programmes of the Business units within portfolio (included local studies NIS, IIR). Identifies, initiates and completes agreed study development activities in a timely manner, be IIR responsible of local IIR. Takes responsibility for all study development activities that they are running in accordance with all applicable external and internal regulations and guidelines. Play a role as local medical expert for Global Clinical Development by providing inputs for medical queries related to trials; participate in site feasibility. Respond to all external scientific and medical queries from physicians, regulatory authorities and public alike in an accurate, transparent and convincing manner in order to position Bayer as a credible, trustworthy and professional leader in the industry. Support the Local Safety Issue and Crisis Management in collaboration with the Headquarters. Support the local Safety Management Team. Reviews all local patient support programs and other undertakings of the local organization with potential consequences on PV obligations (e.g. Market Research, Active-Online-Listening programs) to ensure Pharmacovigilance principles are applied in the interaction with patients. Develops, maintains and strengthens strategic partnership with relevant TLs, societies and associations. Act as medical contact for TL and external Medical experts. In collaboration with local marketing to develop, conduct Advisory Board meetings, Congress and Symposia. WHO YOU ARE: Certified Medical Doctor from a recognized Medical University (MBBS and MD in Pharmacology). More than three (3) years’ of experience as Medical Advisor in Oncology or Hematology Have in depth Disease Area expertise and technical knowledge in the assigned therapeutic areas. For the role is desirable: Experience in driving and managing the medical strategy for Specialty therapy area like Oncology or Hematology. Clinical trial management experience, and be able to interact authoritatively with key stakeholders and investigators. Excellent presentation and teaching skills and to represent the company in a professional manner at medical, scientific and public events. Independent, self-driven, pro-active, collaborative and customer focused. Ability to form relationships quickly and have demonstrable persuasive abilities Highly effective communicator both orally and in writing; can get ideas across one-on-in, in group settings as well as in presentations Highly organized with attention to detail Strong team player and know how to collaborate and engage many stakeholders across a large organization Solid negotiation and decision-making skills Good analytical and numerical abilities Adaptability Innovative Strategic thinking Results-oriented attitude Experience in working with MS office in a Windows environment Willing to travel Ever feel burnt out by bureaucracy? Us too. That's why we're changing the way we work- for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here https://www.bayer.com/enfstrategyfstrategy Bayer does not charge any fees whatsoever for recruitment process. Please do not entertain such demand for payment by any individuals / entities in connection with recruitment with any Bayer Group entity(ies) worldwide under any pretext. Please don’t rely upon any unsolicited email from email addresses not ending with domain name “bayer.com” or job advertisements referring you to an email address that does not end with “bayer.com”. For checking the authenticity of such emails or advertisement you may approach us at HROP_INDIA@BAYER.COM. YOUR APPLICATION Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc. We are committed to treating all applicants fairly and avoiding discrimination. Location: India : Maharashtra : Mumbai Division: Pharmaceuticals Reference Code: 850670 Contact Us + 022-25311234
Posted 1 week ago
0 years
0 Lacs
Gurugram, Haryana, India
On-site
Position Title: Senior Analyst Function: Competitive Strategy (CS) Location: Gurugram Position Overview As a Senior Analyst your time will be divided as follows: 70% conducting secondary research 30% conducting primary research. You will be part of a fast-growing PE-backed business that allows high-performing employees to make an impact and contribute to growing the business. You will have the chance to channel your advanced degree into supporting the development and commercialisation of portfolios, assets, and brands by integrating therapeutic, clinical and commercial expertise to ensure that clients are able to make confident decisions. Through effective collection and analysis of market, competitor, and stakeholder information, you will be responsible for supporting intelligence and insight engagements across our clients’ product and company life cycles. As your clients will be global, the Senior Analyst position requires an understanding of the evolving biopharmaceutical market and trends. Knowledge of drug development and commercialisation is also desirable. Reporting: You will report to a senior executive within Prescient’s India office Time Allocation: 80% of your time will be spent in office, with 20% spent on domestic or international travel (for client meetings, conferences and inter-office visits) To learn more, please visit us at: www.prescienthg.com. Example Responsibilities The following are example responsibilities of this position and are, as such, not meant to be exhaustive, nor convey every responsibility that may vary over time, without changing the essence of this position: Evidence Generation: Secondary Data Analytics: Source, analyse and report published information, be it scientific, clinical, commercial, corporate or regulatory. Primary Research: Collect market, competitor and stakeholder evidence through desk-based interviewing and elicitation. Analysis and Reporting: Collaborate with other members of the project team to analyse findings, develop insights and implications, and create client presentations that deliver a linear, evidence-based story on the topics in focus. Conference Attendance: Cover key conferences with the objectives of interacting with a wide range of experts and delegates and attending key symposia, presentations, posters, and booths. Maintenance of Knowledge Assets: Build data repositories linked to specific therapeutic areas, market dynamics and regulatory dynamics Education, Experience, Knowledge & Other Skills The following criteria outline the minimum hiring criteria for this position, unless otherwise stipulated below as “preferred,” or “a plus.” Undergraduate or advanced degree in life sciences, data sciences, business, or a related discipline, with 2 or more years’ relevant professional experience in a corporate / business or consulting environment. Experience working in oncology, immunology, or biosimilars is preferred. An advanced degree may be required Sound knowledge of life sciences industry and the fundamental practices, principles, and tools used in management consulting, as evidenced by increasing independence in completing assigned work Where applicable, demonstrates strong knowledge of relevant therapeutic / disease areas, functional areas such as pricing /access, manufacturing, etc., markets / regions, and/or industry trends such as personalized healthcare, biosimilars, etc. Understands how to perform primary market research and access and appropriately use secondary market research Customer & Quality Centricity: demonstrable client-centric and quality-oriented mindset and approach with a high level of attention-to-detail Communication: strong communication skills, both written and verbal. Track record of proactive communication in the work environment, including proactively seeking feedback to improve capabilities. Collaboration: strong collaboration skills and proven ability to work well within teams Project Management, Time Management & Organisation: demonstrated abilities to effectively support projects to ensure on-time, within-budget, and high-quality deliverables. Demonstrates high attention-to-detail and quality. Influencing & Stakeholder Management: demonstrated ability to effectively manage routine interactions and communications with stakeholders Achieving Results: consistent track record of meeting or exceeding assigned goals and objectives We are committed to doing our part in the broader communities in which we work and live. As such, all employees will play their part in supporting our broader business mission, vision, purpose and the Prescient brand as well as our commitment toward optimising the social and environmental elements of our communities. We will support these efforts by ensuring regular communications, periodic trainings, volunteering, and other relevant activities. People managers will play a particularly active role in this by assuming responsibilities for certain social and environmental activities that we support as an overall organisation. We are an equal opportunity employer and fully comply with applicable legislation in all the geographies in which we operate. Applicants are considered for positions without regard to veteran status, uniformed service member status, race, colour, religion, sex, national origin, age, physical or mental disability, genetic information or any other category protected by applicable national, federal, state, or local laws.
Posted 2 weeks ago
3.0 years
0 Lacs
Delhi, India
On-site
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. Job Description / Capsule Mentors’ others, has regional impact beyond own geographical area of responsibility. Introduces best practices to peers. Consistently high performer. Job Location: Lucknow. Typical Accountabilities Successfully complete all training requirements, including product examinations. Engage Oncology healthcare professionals in dialogue about approved indications and product efficacy/safety profiles to support on-label prescribing for appropriate patients. Work with Sales Manager to develop a local strategy and business plan to meet or exceed sales and call execution goals in territory Drive sales performance and ensure sales forecasts and assigned budgets meet or exceed therapeutic and territory expectations. Develop and maintain in-depth knowledge of market, demographic, and managed markets information relative to assigned sales territory. Comply with all regulations regarding interactions with healthcare professionals, distribution of samples, etc. Essential Education, Qualifications, Skills and Experience Bachelor’s degree 3 Years experience in Oncology. Desirable MNC Oncology experience / Currently handling GUGYN portfolio Why AstraZeneca? At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare. You can find alternative messaging to use in the ‘Global Talent Attraction Story messaging’ section of the Global Playbook on the Employer Brand Portal - try to use other examples in order to make it different for candidates! So, what’s next? Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you. Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours. If you’re curious to know more then please reach out to (contact person) We welcome with your application, no later than (Month) (XX) Date Posted 21-Jul-2025 Closing Date 22-Jul-2025 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Posted 2 weeks ago
0.0 - 3.0 years
4 - 7 Lacs
Bengaluru
Work from Office
Responsibilities: * Manage client relationships through effective communication. * Generate leads through cold calling and marketing efforts. * Develop new business opportunities within oncology industry.
Posted 2 weeks ago
3.0 - 5.0 years
30 - 35 Lacs
Hyderabad
Work from Office
Career Category Regulatory Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Manager, Global Regulatory Intelligence The Manager in the Global Regulatory Intelligence team is a hands-on contributor responsible for gathering and organizing regulatory intelligence under the guidance of the RI Director. This role often has a technology and data focus , managing the tools and information that drive the intelligence process. Key Responsibilities: Intelligence Gathering & Analysis: Assist in monitoring and analyzing the global regulatory landscape, and in developing intelligence reports and updates as directed by the RI Director. A core duty is to collect and synthesize new or updated local regulatory requirements obtained from Amgen s local regulatory teams, for the Manager s assigned areas of responsibility. This information feeds into the group s centralized knowledge base. The Manager helps execute the regulatory intelligence workplans by preparing agreed deliverables for example, compiling monitoring reports, bulletins, and landscape summaries that highlight regulatory changes or requirements relevant to upcoming filings. They ensure that these deliverables are coherent and actionable, providing clear recommendations or insights where appropriate . Tools & Data Management: Take ownership of the tools, databases, and documentation that support intelligence gathering and dissemination. The Manager is responsible for facilitating and maintaining these systems on a day-to-day basis. This includes ensuring that repositories of regulatory requirements and intelligence reports are up-to-date and accessible to stakeholders. Importantly, the Manager may also be expected to build or modify new tools and databases as needed, not just use existing ones. (For example, if a new tracking database or dashboard is required to capture regulatory changes, the Manager would play a key role in its development or configuration.) Emphasizing this in the job description sets clear expectations that the role involves technical initiative in improving intelligence systems. Cross-Functional Support: Work closely with other members of the Regulatory Policy & Intelligence team and with regulatory staff in various functions to ensure intelligence is applied effectively. The Manager engages with policy analysts, product regulatory leads, and other cross-functional team members to share findings and gather input. While the Manager may not lead cross-functional projects independently, they support these efforts by providing the necessary data or analysis. For instance, if a cross-product regulatory strategy project is underway, the Manager might supply the compiled country requirements or recent regulatory changes needed for decision-making. They help ensure that agreed intelligence deliverables are executed on time and that any intelligence requests from internal stakeholders are addressed promptly. Progress Tracking & Improvement: Monitor the progress of intelligence-gathering activities against the team s objectives and timelines. The Manager tracks their assignments (e.g., monitoring tasks or updates due) and regularly reports status to the RI Director. If there are delays or obstacles in obtaining information, the Manager flags these and helps troubleshoot solutions. Additionally, the Manager contributes to process improvement discussions identifying any inefficiencies in how intelligence data is collected or shared and suggesting enhancements. They participate in continuous improvement of the function s processes and tools, helping to refine workflows for greater efficiency and reliability. Knowledge & Skills: Regulatory Knowledge: A solid grounding in regulatory affairs processes and requirements is needed. The Manager should understand regulatory submission guidelines and procedures across different regions (major markets and smaller markets) and have familiarity with how local regulations impact drug development and filings. While they may rely on senior staff for deeper analysis, the Manager must be able to interpret regulatory documents or health authority guidance and extract key points. The ability to handle complex information and distill it into clear summaries is crucial often the Manager will be the first to review new regulations and must highlight what matters to Amgen s products. Attention to Detail and Analytical Skills: The role requires strong analytical abilities and attention to detail. The Manager will be dealing with regulatory texts, tracking changes, and inputting data into intelligence systems so accuracy is paramount. They should be skilled at comparing regulatory requirements and spotting differences or trends. At the same time, they need to maintain a big-picture view to recognize how a particular change might affect Amgen s global filing strategy. Being able to propose practical solutions or escalate important findings is part of this analytical skill set. Technical and Project Skills: Proficiency in using information systems and databases is important, as this role often acts as the power user of regulatory intelligence tools. Experience with managing or configuring databases, spreadsheets, or tracking tools will be useful. The Manager should also have good project coordination skills capable of managing their own workstreams, meeting deadlines, and juggling multiple intelligence requests or projects. Strong written and oral communication skills are needed to draft clear reports and to communicate findings to the team or other stakeholders. Additionally, a willingness to learn and even create new technical solutions (e.g., leveraging an internal SharePoint site or an intelligence software platform) is highly valued in this position. Qualifications: Education & Experience: It is recommended that candidates have at least a Bachelor s degree in a relevant discipline (such as life sciences or regulatory affairs) plus relevant experience in regulatory or drug development roles. An advanced degree ( Master s or higher) in a related field is a plus. While Amgen s internal templates for similar roles have sometimes listed lower educational minima ( e.g. associate degree or high school with significant years of experience), for a Regulatory Intelligence Manager it is preferable to require a Bachelor s degree as the minimum qualification . This ensures the candidate has a sufficient foundation to grasp complex regulatory information. In terms of experience, a few years of hands-on regulatory affairs or regulatory operations experience (for instance, ~3-5 years with a Bachelor s degree ) would likely be expected, given the need to work independently and with understanding of the regulatory context. Preferred Background: Relevant industry experience in pharmaceutical/biotech regulatory affairs or compliance is strongly preferred. Experience specifically with regulatory intelligence or policy tracking whether in a prior role or via project work would allow a new hire to hit the ground running. Familiarity with regulatory intelligence tools or subscription databases (such as Tarius or similar services) and experience interacting with global regulatory colleagues would also be advantageous . The ideal candidate will be one who not only has the technical skills to manage data and tools, but also the curiosity and insight to understand why regulatory changes matter and how to communicate those insights effectively.
Posted 2 weeks ago
1.0 - 3.0 years
18 - 20 Lacs
Hyderabad
Work from Office
Let s do this. Let s change the world. In this vital role you will responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers to create high-quality, scalable software solutions and automating operations, monitoring system health, and responding to incidents to minimize downtime. Roles & Responsibilities: Develop and maintain Validation Plans, including scope, responsibilities, deliverables, and timelines. Perform risk-based assessments to determine the level of validation required. Assist in defining User Requirements and Functional Requirements. Draft and review various validation artifacts. Ensure all documents are compliant with 21 CFR Part 11, Annex 11, and other relevant regulations. Coordinate and/or execute validation protocols. Support change management processes for validated systems. Ensure continuous validation throughout the system lifecycle (including periodic reviews). Work closely with multi-functional teams, including product management, design, and QA, to deliver high-quality software on time. Stay updated with the latest trends and technologies, and related fields. Provide ongoing support and maintenance for applications, ensuring that they operate smoothly and efficiently. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 1 to 3 years of related field experience OR Bachelor s degree and 3 to 5 years of related field experience OR Diploma and 7 to 9 years of related field experience Strong technical background, including understanding software development processes, databases, and cloud-based systems. Experience implementing CSA guidance and validating computer systems. Experience working with databases (SQL/NoSQL). Strong foundational knowledge of testing methodologies. Preferred Qualifications: Basic understanding of Veeva Validation Management/ALM/KNEAT. Strong understanding of SaaS, MuleSoft, Change Control, Incident Management, document management. Strong Business Analysis skills with basic Veeva configuration knowledge. Excellent communication skills, with the ability to convey complex technical concepts. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Posted 2 weeks ago
1.0 - 3.0 years
18 - 20 Lacs
Hyderabad
Work from Office
Let s do this. Let s change the world. In this vital role you will be a skilled Software Test engineer to develop, implement and maintain the test scripts for data platforms and custom-built solutions. This is a hands-on, growth-oriented position ideal for someone looking to deepen their skills in Front-end testing, Back-end testing, API testing, and test automation. As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and align with Amgen s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. Roles & Responsibilities: The ideal candidate will be accustomed to working in Web applications and should be actively involved in various types of testing such as Functional, System, Stress, Performance, Integration, Regression, Database, and Beta. Actively involved in release planning and estimate test efforts Collaborate and test in an Agile development environment Analyze and communicate test results to team and manager Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards. Contribute to test automation scripting, framework maintenance, and CI/CD integration. Implement automated test suites across various layers including data pipelines, APIs, and semantic layers. Analyze test automation results, identify failures or inconsistencies, and assist in root cause analysis. Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and platform teams to drive validation activities and meet project deadlines. Work closely with manager on implementing automation strategies, document all bugs in a tracking tool, and always follow the best QA practices Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management. Identify opportunities for process improvements in validation activities. Stay ahead of on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Master s degree and 1 to 3 years of Computer Science, IT or related field experience Or Bachelor s degree and 3 to 5 years of Computer Science, IT or related field experience Preferred Qualifications: Must-Have Skills: 3+ years of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). 6-8 Years overall experience in Testing & Validation Projects 2 to 4 years overall experience in QA & Test Automation is expected. Experience leading software validation projects. Proficiency in developing and implementing validation protocols (IQ, OQ, PQ), reports, and related documentation. Hands-on experience implementing and analyzing automated test suites Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and collaboration skills. Good-to-Have Skills: Experience with automated and computer-controlled systems validation (21 CFR Part 11) Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to balance multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Ability to learn quickly, be organized and detail oriented. Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Posted 2 weeks ago
3.0 - 5.0 years
18 - 20 Lacs
Hyderabad
Work from Office
We are seeking a highly skilled Validation Engineer to join our team. You will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers to create high-quality, scalable software solutions and automating operations, monitoring system health, and responding to incidents to minimize downtime. Roles & Responsibilities: Develop and maintain Validation Plans, including scope, responsibilities, deliverables, and timelines. Perform risk-based assessments to determine the level of validation required. Assist in defining User Requirements and Functional Requirements. Draft and review various validation artifacts. Ensure all documents are compliant with 21 CFR Part 11, Annex 11, and other relevant regulations. Coordinate and/or execute validation protocols. Support change management processes for validated systems. Ensure continuous validation throughout the system lifecycle (including periodic reviews). Work closely with cross-functional teams, including product management, design, and QA, to deliver high-quality software on time. Stay updated with the latest trends and technologies, and related fields. Provide ongoing support and maintenance for applications, ensuring that they operate smoothly and efficiently. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 1 to 3 years of experience in Computer Science, IT or related field experience OR Bachelor s degree and 3 to 5 years of experience in Computer Science, IT or related field experience OR Diploma and 7 to 9 years of experience in Computer Science, IT or related field experience Must-Have Skills: Strong technical background, including understanding software development processes, databases, and cloud-based systems. Experience implementing CSA guidance. Experience with product backlog management (e.g., Jira) and collaboration tools. Preferred Qualifications: Basic understanding of Veeva Quality Vault. Strong Analysis skills with basic Veeva configuration knowledge. Excellent communication skills, with the ability to convey complex technical concepts. Soft Skills: Excellent analytical and problem-solving skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Equal opportunity statement
Posted 2 weeks ago
3.0 - 5.0 years
2 - 6 Lacs
Hyderabad
Work from Office
Let s do this. Let s change the world. In this vital role We are seeking a skilled UI Developer to design, develop, and maintain high-quality, scalable software solutions. Contribute to a team delivering complex software projects from conception to deployment , managing scope, risk, and timelines. Rapidly prototype and translate concepts into functional code. Develop responsive, user-friendly UIs using React.js, JavaScript, TypeScript, HTML5, and CSS . Ensure UI accessibility and performance optimization through standard processes. Conduct code reviews and document software architecture and design. Develop and integrate with RESTful APIs, databases (MySQL, PostgreSQL, SQL Server) , and cloud platforms (AWS, Azure) . Implement testing strategies (unit, integration, UI testing with Jest, Enzyme, Cypress). Automate operations, monitor system health, and respond to incidents to minimize downtime. Collaborate with cross-functional teams including Product, Design, and QA. Customize modules and ensure seamless data flow and system integrations. Stay current with industry trends and recommend technology improvements. What we expect of you We are all different, yet we all use our unique contributions to serve patients. This role involves working closely with product managers, designers, and engineers to build and optimize UI applications, leveraging cloud technology and generative AI . The ideal candidate will be proficient in front-end development, have strong problem-solving abilities, and contribute to system performance, automation, and integration efforts. Basic Qualifications: Master s degree and 1 to 3 years expereince in Computer Science, Data Science, Information Systems, or related field OR Bachelor s degree and 3 to 5 years of in Computer Science, Data Science, Information Systems, or related field OR Diploma and 7 to 9 years of in Computer Science, Data Science, Information Systems, or related field Preferred Qualifications: Technical leadership in agile environments . Strong understanding of software development methodologies (Agile, Scrum). Excellent problem-solving, communication, and collaboration skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Posted 2 weeks ago
3.0 - 5.0 years
18 - 20 Lacs
Hyderabad
Work from Office
Let s do this. Let s change the world. In this vital role you will join a collaborative team implementing and supporting the integrated case management systems on existing & future technologies. In this role, you will wear multiple hats including writing test scripts, implementing, analyze and resolve issues with case intake and data transfer across integrated systems. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient processing of data. Roles & Responsibilities: Monitor, test, and resolve issues related to case intake and case processing across multiple systems. Work closely with internal teams, external vendors, and business partners to address dependencies and resolve bottlenecks for critical issues Ownership in the development of test plans, scenarios to ensure robust validation of system updates, patches and new features Create test scripts, perform regression & functional testing to verify the changes do not negatively impact existing system functionality What we expect of you We are all different, yet we all use our unique contributions to serve patients. Master s degree and 1 to 3 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Bachelor s degree and 3 to 5 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Diploma and 7 to 9 years of Life Science / Biotechnology / Pharmacology / Information Systems experience Preferred Qualifications: Functional Skills (Must Have) Experience in user requirements and acceptance criteria in agile project management systems such as JIRA and identification and execution of scripts. Experience in management of test plan, test protocols, defect management, and requirements traceability matrix Hands-on experience with the ITIL framework and methodologies like (Scrum). Hands on experience in HP ALM, JIRA, Visio, document management systems (e.g: Veeva) and Service Now. Good to Have Experience of DevOps, Continuous Integration, and Continuous Delivery methodology, and CRM systems Excellent communication skills and the ability to collaborate with Product Managers and business collaborators to define scope and value for new developments Soft Skills: Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Team-oriented, with a focus on achieving team goals Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Posted 2 weeks ago
6.0 - 8.0 years
22 - 27 Lacs
Hyderabad
Work from Office
Amgen harnesses the best of biology and technology to fight the world s toughest diseases, and make people s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what s known today. In this role you will be serving patients through internal collaboration with Amgen s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to fulfill Amgen s missions of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients. The Senior Validation Engineer will oversee strategies and documents related to DS/DP Process Performance Qualification, Cleaning Validation, and Packaging Qualification at contract manufacturing organizations (CMOs) located across North America, Europe and JAPAC regions. The candidate should have prior experience with qualification of the following modalities, primarily: synthetic API/DS and DP manufacturing, FDP and packaging qualification, and aseptic DP. Be an integral quality member of Amgen cross-functional contract manufacturing teams that includes but is not limited to operations, analytical science, process development, supply chain, etc. Project teams will include: tech transfers, new product introductions, and ongoing validation maintenance activities. Roles & Responsibilities: Translate Amgen requirements into the language of the CMO Identify and assess validation/quality risks to enable risk-based decisions Validation document author/approver Determine appropriate sample plans and acceptance criteria for primary and secondary packaging processes. Aseptic processing system oversight (media fill, autoclave validation, EM) Prepare materials/documents (playbooks) for topics to be presented during audits/inspections Perform validation change control assessments Review/approve validation deviations Review/approve Master Batch Records Perform Person in Plant activities as required Escalate issues to Validation/Quality management, as needed Author Validation sections of Marketing Applications Write/review responses to regulatory questions (RTQs) Drive Operational Excellence and Champion Change Authority: Determine outcome of validation activities Decision to approve or reject validation documentation Provide input on Validation position on related topics and strategy for the site Decision to approve Master batch Records This role may require working in shifts or extended hours within the same shift to support global time zones. What we expect of you Basic Qualifications and Experience: Doctorate degree OR Master s degree with 4 to 6 years of experience in process validation or a related field OR Bachelor s degree with 6 to 8 years of experience in process validation or a related field OR Diploma with 10 to 12 years of experience in process validation or a related field. Functional Skills: Must-Have Skills: Prior experience serving as Validation lead for NPI or tech transfer of manufacturing processes. Relevant experience in qualification of finished drug product and packaging processes. Minimum of 6 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations. Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them Good-to-Have Skills: Working foundation in cleaning validation and aseptic process simulation.Experience in resolving complex deviations associated with validation studies. Understanding of the applicable manufacturing/testing processes (i.e. Synthetic API, Drug Substance, Drug Product, Packaging, Device manufacturing processes). Proven experience in designing and/or improving processes at conceptual level Desire to partner with internal and external stakeholders across teams Understanding of industry requirements/expectations that comprise a robust Validation package. Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Posted 2 weeks ago
7.0 - 8.0 years
4 - 7 Lacs
Hyderabad
Work from Office
Let s do this. Let s change the world. In this vital role you will take ownership of Transportation Master data processes, ensuring the accuracy, consistency, and governance of critical data across the organization. This role will lead data validation, cleansing, and enrichment efforts, and collaborate with cross-functional teams to resolve complex data issues and drive process improvements. The Transportation Master Team Lead will also oversee key performance metrics, ensure compliance with data governance standards, and lead data migration and integration initiatives. Roles & Responsibilities: Lead and manage day-to-day MDM operations, including data validation, cleansing, and enrichment processes Oversee data governance practices, ensuring compliance with internal standards and regulatory requirements Collaborate with cross-functional teams, including IT and business units, to resolve complex data issues and improve data workflows. Implement and drive continuous improvements in MDM processes to enhance data accuracy, quality, and operational efficiency. Lead data migration, integration projects, and system upgrades to ensure seamless data consistency across platforms. Monitor and report on key performance indicators related to master data quality and operational success. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Bachelor s in a STEM discipline and 7-8 years of experience in enterprise applications like SAP, and Oracle, proven experience in Transportation Master data management and data governance Industry experience preferably in healthcare or biotech supply chain Proficient in MS Office, visualization tools like Spotfire, Tableau, Power BI Strong analytical skills with the ability to collaborate cross-functionally and resolve data issues. Experience in leading and managing successful teams Preferred Qualifications: Must-Have Skills: Expertise in master data management processes and data governance Solid understanding of SAP ECC and proven experience in data implementation/integration projects Master data knowledge in the Transportation domain, other domains such as Material, Customer, and Production Master are a plus. Ability to lead and collaborate with cross-functional teams to set data strategy for a master domain(s) and drive prioritization across different projects and day-to-day operations Strong understanding of data governance frameworks and regulatory compliance standards and regulations (e.g., GDPR, HIPAA, GxP). Excellent problem-solving and analytical skills, with a focus on driving continuous improvement in data accuracy and quality Good-to-Have Skills: SAP S/4, SAP MDG, SAP TM Professional Certifications (please mention if the certification is preferred or mandatory for the role): Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Posted 2 weeks ago
4.0 - 6.0 years
20 - 25 Lacs
Hyderabad
Work from Office
Let s do this. Let s change the world. In this vital role you will be part of the Chromatography Data Systems (CDS) Product Team working on computerized systems validations (CSV) and GAMP (Good Automated Manufacturing Practice). This vital role ensures Amgen systems remain aligned with industry standards and align with all regulatory requirements. Roles & Responsibilities: Advising clients on how to meet compliance requirements using a risk-based approach. Develop validation documentation and standard operating procedures for various GxP applications. Develop test protocols that thoroughly test business requirements. Provide test execution oversight and assist with deviation recommendations as required, work with clients to develop validation plans to ensure that, at the end of the project, the system meets GxP requirements. Work with client business functions and domain experts to develop User Requirements Specification, Functional Requirements Specification, and/or Design Specifications as required Development of test / validation scripts based on software design and configurations. Develop IQ/OQ scripts as required. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Doctorate degree OR Master s degree and 4 to 6 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Bachelor s degree and 6 to 8 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Diploma and 10 to 12 years of Life Science / Biotechnology / Pharmacology / Information Systems experience Preferred Qualifications: Functional Skills: Must-Have Skills: Demonstrated experience with minimum of 3 to 5 years in pharmaceutical industry, focusing on Computer Systems Validations / GAMP Experience with regulatory agencies - FDA, EMEA, CFDA, and other regulatory agencies Proven leadership skills with the ability to multitask and lead multiple validation projects Thorough understanding of the principles of GAMP, SDLC methodologies and testing standard methodology. Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems. Expertise with ALM testing and ALM software (HP) Expertise in use - Veeva (all modules - CDocs, QMS, RIM, DocuSign, etc) Fluent knowledge of rules and regulations: GAMP 5, 21 CFR Part 11 Compliance and CFR Part 210, 211 Compliance. Good-to-Have Skills: Ability to work independently, excellent problem solving and professional written communications skills. Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project), Experience with Smartsheets, Salesforce, Tableau a plus FDA Audit experience a plus & working with regulatory agencies Experience with enterprise CDS platform software (Empower/Chromeleon/Unicorn) Soft Skills: Excellent leadership and team management skills. Strong transformation and organizational change experience. Ability to work effectively with global, virtual teams. Excellent analytical and solving skills. Ability to prioritise successfully. Strong presentation and public speaking skills. Strong verbal and written communication skills. High degree of initiative and self-motivation. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers driven and comprehensive Total Rewards Plans that are aligned with local industry standards.
Posted 2 weeks ago
4.0 - 6.0 years
15 - 20 Lacs
Hyderabad
Work from Office
Let s do this. Let s change the world. In this vital role you will be responsible for defining the architecture vision, creating roadmaps, and ensuring that IT strategies align with business goals. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements scientific software platforms that manage compound inventories / biological sample banks, as well as those that enable the capture, analysis, storage, and report of in vitro assays and in vivo / pre-clinical studies. You will play a pivotal role in shaping the software ecosystem in this area, ensuring that it meets both current and future business needs while providing technical leadership to junior team members. Create and maintain architectural roadmaps that guide the evolution of IT systems and capabilities Maintain documentation of the architecture, including principles, standards, and models Drive continuous improvement in the architecture by identifying opportunities for innovation and efficiency Work with stakeholders to gather and analyze requirements, ensuring that solutions meet both business and technical needs Evaluate and recommend technologies and tools that best fit the solution requirements Ensure seamless integration between systems and platforms, both within the organization and with external partners Design systems that can scale to meet growing business needs and performance demands What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 4 to 6 years of Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Bachelor s degree and 6 to 8 years of Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Diploma and 10 to 12 years of Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field. Preferred Qualifications and Experience: 3+ years of experience in implementing and supporting biopharma scientific research software platforms Must-Have Skills: Strong architectural design and modeling skills Experience with system integration, IT infrastructure Experience directing solution design, business processes redesign and aligning business requirements to technical solutions in a regulated environment Experience working in agile methodology, including Product Teams and Product Development models Good-to-Have Skills: Problem-Solving: Ability to identify and solve complex technical challenges. Solution Design: Proficiency in designing scalable, secure, and cost-effective solutions. Vendor Management: Experience in evaluating and selecting technology vendors. Proof of Concept: Ability to create and demonstrate proof of concept solutions to validate technical feasibility. Systems Analysis: Ability to decompose complex systems into smaller, manageable components. Design Patterns: Knowledge of common design patterns and their application in software development. Non-Functional Requirements: Consideration of factors like performance, scalability, security, and reliability in system design. Integration: Understanding of system integration principles and technologies (e.g. Mulesoft, AWS Kafka) Technology Stack: Familiarity with a variety of programming languages (e.g. Python, Java), frameworks, databases (e.g. Oracle, MySQL) and Salesforce Experience with cloud computing platforms (AWS) Strong solution design and problem-solving skills Strong understanding of technology, function, or platform Experience in developing differentiated and deliverable solutions Ability to analyze client requirements and translate them into solutions Soft Skills: Excellent critical-thinking and problem-solving skills Strong communication and collaboration skills Demonstrated awareness of how to function in a team setting Demonstrated awareness of presentation skills Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. .
Posted 2 weeks ago
1.0 - 3.0 years
20 - 25 Lacs
Hyderabad
Work from Office
Let s do this. Let s change the world. In this vital role you will be responsible for designing, developing, and maintaining software solutions for Research scientists. Additionally, it involves automating operations, monitoring system health, and responding to incidents to minimize downtime. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements LIMS platforms that enable the capture, analysis, storage, and report of pre-clinical and clinical studies as well as those that manage biological sample banks. The ideal candidate possesses experience in the pharmaceutical or biotech industry, strong technical skills, and full stack software engineering experience (spanning SQL, back-end, front-end web technologies, automated testing). Design, develop, and implement applications and modules, including custom reports, interfaces, and enhancements Analyze and understand the functional and technical requirements of applications, solutions and systems and translate them into software architecture and design specifications Develop and execute unit tests, integration tests, and other testing strategies to ensure the quality of the software Identify and resolve software bugs and performance issues Work closely with cross-functional teams, including product management, design, and QA, to deliver high-quality software on time Maintain detailed documentation of software designs, code, and development processes Customize modules to meet specific business requirements Work on integrating with other systems and platforms to ensure seamless data flow and functionality Provide ongoing support and maintenance for applications, ensuring that they operate smoothly and efficiently Possesses strong rapid prototyping skills and can quickly translate concepts into working code Contribute to both front-end and back-end development using cloud technology Develop innovative solution using generative AI technologies Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations Identify and resolve technical challenges effectively Stay updated with the latest trends and advancements Work closely with product team, business team including scientists, and other stakeholders What we expect of you Master s degree and 1 to 3 years of Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Bachelor s degree and 3 to 5 years of Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Diploma and 7 to 9 years of Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field. Basic Qualifications: Proficient in C#.NET Proficient in a Javascript UI Framework (e.g. React, ExtJs) Proficient in SQL (e.g. Oracle, PostGres, Databricks) Experience with Event-based architecture (e.g. Mulesoft, AWS EventBridge, AWS Kinesis, Kafka) Preferred Qualifications: 1+ years of experience in implementing and supporting LIMS platforms Strong understanding of software development methodologies, mainly Agile and Scrum Hands-on experience with Full Stack software development Strong understanding of cloud platforms (e.g AWS) and containerization technologies (e.g., Docker, Kubernetes) Working experience with DevOps practices and CI/CD pipelines Experience with big data technologies (e.g., Spark, Databricks) Experience with API integration, serverless, microservices architecture (e.g. Mulesoft, AWS Kafka) Experience with monitoring and logging tools (e.g., Prometheus, Grafana, Splunk) Experience of infrastructure as code (IaC) tools (Terraform, CloudFormation) Experience with version control systems like Git Experience with automated testing tools and frameworks Experience with STARLIMS, Watson, LabVantage, or similar LIMS platforms Professional Certifications: AWS Certified Cloud Practitioner (preferred) Soft Skills: Excellent problem solving, analytical, and troubleshooting skills Strong communication and interpersonal skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to learn quickly & work independently Team-oriented, with a focus on achieving team goals Ability to manage multiple priorities successfully Strong presentation and public speaking skills EQUAL OPPORTUNITY STATEMENT We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation . .
Posted 2 weeks ago
2.0 - 7.0 years
20 - 25 Lacs
Hyderabad
Work from Office
Let s do this. Let s change the world. The Global HEOR Systematic Literature Review (SLR) Leader oversees the development and delivery of systematic literature review activities within Amgen s Global HEOR function. This operational and managerial role includes supervision of a team of Global HEOR SLR Analysts, ensuring high-quality, timely, and scientifically robust literature review outputs. The Global HEOR SLR Leader will align closely with Global HEOR TA Heads in support of global market access and value demonstration for Amgen s products across their lifecycle. Lead, mentor, and handle a team of Global HEOR SLR Analysts, fostering a high-performance culture. Oversee the design, execution, and quality control of systematic literature reviews across therapeutic areas. Supervise the development of research protocols, screening strategies, and data abstraction tools. Collaborate with HEOR TA Heads to align literature review outputs with HEOR strategy. Serve as the functional guide on literature review within HEOR. Ensure consistency with PRISMA, PICOS, and other industry standards for evidence synthesis. Support integration of SLRs into HTA submissions, global value dossiers, and peer-reviewed publications. Continuously improve workflows, tools, and methodologies to enhance review efficiency and quality. Contribute to hiring, training, and performance evaluations within the SLR team. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The HEOR Systematic Literature Review Leader we seek should possess these qualifications. Basic Qualifications & Experience: Doctorate degree in health economics, public health, Epidemiology, Pharmacy, life sciences or related field and 2 years of experience in systematic literature reviews and evidence synthesis in the pharmaceutical, biotech or consulting setting OR, Master s degree in Health Economics, Public Health, Epidemiology, Pharmacy, life sciences or related field and 8 to 10 years of experience in systematic literature reviews and evidence synthesis in the pharmaceutical, biotech or consulting setting OR, Bachelor s degree in Health Economics, Public Health, Epidemiology, Pharmacy, life sciences or related field and 10 to 14 years of experience in systematic literature reviews and evidence synthesis in the pharmaceutical, biotech or consulting setting OR, Diploma in Health Economics, Public Health, Epidemiology, Pharmacy, life sciences or related field and 14 to 18 years of experience in systematic literature reviews and evidence synthesis in the pharmaceutical, biotech or consulting setting 3+ years of experience in team management capacity. Skills & Competencies: Exceptional leadership, mentoring, and project management skills. Excellent English oral and written communication, with ability to tailor content to different key partners; past medical writing experience is a plus Advanced proficiency with systematic review tools and citation databases (e.g., PubMed, EMBASE). Skilled in Microsoft Office (Word, PowerPoint, Excel); experience with EndNote or other reference tools preferred. High attention to detail, quality assurance, and evidence integrity. Innovative use of artificial intelligence to boost efficiency Organizational Behaviors: Solution-oriented with a continuous improvement attitude. Strong interpersonal and customer engagement capabilities. Comfortable working in a distributed team across time zones and cultures. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Posted 2 weeks ago
2.0 - 7.0 years
20 - 25 Lacs
Hyderabad
Work from Office
Let s do this. Let s change the world. In this vital role you will serve as an operational and technical leader responsible for overseeing a team of Global HEOR Economic Modelers. This role ensures the development of innovative, scientifically rigorous, and high-quality economic models supporting Amgen s global market access and pricing strategies. The position requires close collaboration with Global HEOR TA Heads to align health economics deliverables with product strategies. Lead, mentor, and develop a team of Global HEOR Economic Modelers to ensure dedication and continuous professional growth. Provide technical direction and oversight for the development of economic models, including cost-effectiveness/cost-utility (e.g., markov, partitioned survival model), cost minimization, budget impact, and other techniques, as appropriate. Drive innovation and standardization in health economic modeling methodologies across portfolio. Ensure alignment of modeling activities with HEOR TA Heads and product strategies. Maintain expert-level understanding of global HTA requirements and evolving payer needs, integrating them into the team s economic modeling approaches. Oversee model documentation and ensure quality control and compliance with internal and external standards. Contribute to hiring, training, and performance evaluations within the team. Continuously improve workflows, tools, and methodologies to enhance efficiency and quality of work. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Economic Modeling Leader we seek should possess these qualifications. Basic Qualifications: Doctorate degree in Health Economics, Econometry, Biostatistics, Mathematics, Engineering or a related field and 2 years of experience in health economic modeling within the pharmaceutical, biotechnology, or consulting sectors OR, Master s degree in Health Economics, Econometry, Biostatistics, Mathematics, Engineering or a related field and 8 to 10 years of experience in health economic modeling within the pharmaceutical, biotechnology, or consulting sectors OR, Bachelor s degree in Health Economics, Econometry, Biostatistics, Mathematics, Engineering or a related field and 10 to 14 years of experience in health economic modeling within the pharmaceutical, biotechnology, or consulting sectors OR, Diploma in Health Economics, Econometry, Biostatistics, Mathematics, Engineering or a related field and 14 to 18 years of experience in health economic modeling within the pharmaceutical, biotechnology, or consulting sectors 3+ years of experience in team management capacity. Consistent track record of supporting HTA submissions and payer evidence generation globally. Expert proficiency with modeling and statistical tools such as Excel, R, SAS, or STATA. Skills & Competencies: Strong leadership and key customer engagement skills. Excellent English oral and written communication, with ability to tailor content to different customers. Advanced quantitative and analytical abilities with exceptional attention to detail. Deep knowledge of HTA processes and payer landscapes across major markets. Innovative use of artificial intelligence to boost efficiency. Organizational Behaviors: Proactive leadership with a collaborative approach. Comfortable working in a distributed team across time zones and cultures. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Posted 2 weeks ago
5.0 - 9.0 years
20 - 25 Lacs
Hyderabad
Work from Office
Let s do this. Let s change the world. In this vital role you will be member of the technical team that develops and implements technology strategies, solutions, and services to support Amgen s Global Medical business function. As the Technology IS Engineer, you will be the primary accountable for ownership and integration of several capabilities and the point of contact for the business & technology product owner and other stakeholders. This role will work closely with business and technology teams to efficiently build, deploy, scale, and operate technology solutions and software products and be responsible for all aspects of product DevOps, MLOps and lifecycle management. The Senior Associate IS Engineer will be a responsible member of a high-performing Agile Product Team consisting of business analysts, software engineers, solution architects, system configurators, etc. Roles & Responsibilities: Be accountable for the identified agile product team and portfolio of software applications Enable the technology ecosystem for Global Medical Data and Analytics platform team and ensure that the platforms meet their business needs and enterprise technology standards Own the Product DevOPS Implementation of integration pipelines for the product using Amgen s CI/CD frameworks and tools Manage development to deployment of data integration User Stories, Data pipelines and APIs using city planning technology using tools like AWS, Databricks, MuleSoft, salesforce connectors, Python Develop cross-functional collaborations with platform teams to maintain enterprise standards Drive a Product First attitude amongst the team and peers with a goal towards global expansion of the product s capabilities Drive an attitude of excellence in running robust, reliable, and secure software products following Amgen s software development, operating procedures, and change management requirements Unblock and drive engagement to improve results delivery for the team and the organization Drive external software product and service partners to deliver excellence Develop and mentor the team of engineers, architects, and data scientists for higher performance, and individual career growth. Act as a role model demonstrating leadership behaviors Partner with leadership in the Global Medical organization to define, develop, and implement technology solutions aligned with the organization s goals and objectives, with a focus on increasing the effectiveness of the organization. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Masters degree / Bachelors degree and 5 to 9 years of Information Systems experience. Preferred Qualifications: Functional Skills 5+ years of IT Industry work experience in analysis, design, development, testing and maintenance of software applications in the Health & Life Sciences industry 2+ years of experience supporting Medical Affairs business teams Experience working on major programs/projects that involve multiple partners and external vendors Experience in end-to end DevOps, and Scaled Agile Framework (SAFe), especially in regulated setting including ability to lead the transformation of teams from a service based to a product-based model Working experience on Enterprise Datalake(EDL) and technologies like AWS, GitLab, GitHUB, Databricks, Mulesoft, SQL, Spark, Python, MLOps etc. In-depth experience in all aspects of SDLC from requirements, design, testing, data analysis and Change Control process combined with experience developing project charters, statement of work and project financials Experience with data warehousing and EDL technologies like databricks to build integrations across multiple systems An ongoing commitment to learning and staying at the forefront of AI/ML advancements. Experience or working knowledge of SaaS solutions like Salesforce, Veeva, AWS, etc. Experience within a highly regulated pharmaceutical or technology organization, with the ability to ensure compliance with industry regulations and standard methodologies for data integrity, security, and audit readiness. Experience driving a collaborative culture that values technical depth, accountability, and customer service. Strong problem-solving and analytical skills. Demonstrated ability to work effectively in a fast-paced, dynamic environment. Experience handling vendor relationships and working with external partners or consultants to ensure optimal performance, support, and development of the ServiceNow platform Professional Certifications Preferred certification in SAFe for Teams Preferred certification in EDL tools like databricks Preferred AWS certifications Soft Skills: Excellent leadership skills with the ability to work in collaborative teams and cultivate talent. Demonstrated ability to influence decisions with business & technology collaborators & leadership Data-driven decision making Excellent verbal and written communication skills for technical and non-technical audiences of various levels in the organization. High degree of initiative and self-motivation Ability to handle multiple priorities successfully Team-oriented with a focus on achieving team goals Strong presentation and public speaking skills Excellent analytical and troubleshooting skills Ability to work effectively with global, virtual teams Equal opportunity statement We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .
Posted 2 weeks ago
8.0 - 10.0 years
20 - 25 Lacs
Hyderabad
Work from Office
Let s do this. Let s change the world. In this vital role you will lead the engagement model between Amgens Technology organization and our global business partners in Commercial Data & Analytics. We seek a technology leader with a passion for innovation and a collaborative working style that partners effectively with business and technology leaders. Are you interested in building a team that consistently delivers business value in an agile model using technologies such as AWS, Databricks, Airflow, and Tableau? Come join our team! Roles & Responsibilities: Establish an effective engagement model to collaborate with senior leaders on the Sales Insights product team within the Commercial Data & Analytics organization, focused on operations within the United States Serve as the technology product owner for an agile product team committed to delivering business value to Commercial stakeholders via data pipeline buildout for sales data Lead and mentor junior team members to deliver on the needs of the business Interact with business clients and technology management to create technology roadmaps, build cases, and drive DevOps to achieve the roadmaps Help to mature Agile operating principles through deployment of creative and consistent practices for user story development, robust testing and quality oversight, and focus on user experience Ability to connect and understand our vast array Commercial and other functional data sources including Sales, Activity, and Digital data, etc. into consumable and user-friendly modes (e.g., dashboards, reports, mobile, etc.) for key decision makers such as executives, brand leads, account managers, and field representatives. Become the lead subject matter expert in reporting technology capabilities by researching and implementing new tools and features, internal and external methodologies What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree with 8 - 10 years of experience in Information Systems experience OR Bachelor s degree with 10 - 14 years of experience in Information Systems experience OR Diploma with 14 - 18 years of experience in Information Systems experience Must-Have Skills Excellent problem-solving skills and a passion for tackling complex challenges in data and analytics with technology Experience leading data and analytics teams in a Scaled Agile Framework (SAFe) Excellent interpersonal skills, strong attention to detail, and ability to influence based on data and business value Ability to build compelling business cases with accurate cost and effort estimations Has experience with writing user requirements and acceptance criteria in agile project management systems such as Jira Ability to explain sophisticated technical concepts to non-technical clients Strong understanding of sales and incentive compensation value streams Preferred Qualifications: Jira Align & Confluence experience Experience of DevOps, Continuous Integration, and Continuous Delivery methodology Understanding of software systems strategy, governance, and infrastructure Experience in managing product features for PI planning and developing product roadmaps and user journeys Familiarity with low-code, no-code test automation software Technical thought leadership Soft Skills: Able to work effectively across multiple geographies (primarily India, Portugal, and the United States) under minimal supervision Demonstrated proficiency in written and verbal communication in English language Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Intellectual curiosity and the ability to question partners across functions Ability to prioritize successfully based on business value High degree of initiative and self-motivation Ability to manage multiple priorities successfully across virtual teams Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Technical Skills: ETL tools: Experience in ETL tools such as Databricks Redshift or equivalent cloud-based dB Big Data, Analytics, Reporting, Data Lake, and Data Integration technologies S3 or equivalent storage system AWS (similar cloud-based platforms) BI Tools (Tableau and Power BI preferred) What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Posted 2 weeks ago
8.0 - 10.0 years
20 - 25 Lacs
Hyderabad
Work from Office
Let s do this. Let s change the world. In this vital role you will [operationalize the Enterprise Data Council vision across specific domains (Research, Clinical Trials, Commercial, etc.). They will coordinate activities at the tactical level, interpreting Enterprise Data Council direction and defining operational level impact deliverables and actions to build data foundations in specific domains. The Data Strategy and Governance Lead will partner with senior leadership and other Data Governance functional leads to align data initiatives with business goals. They will establish and enforce data governance policies and standards to deliver high-quality data, easy to reuse and connect to accelerate AI innovative solutions to better serve patients Roles & Responsibilities: Responsible for data governance and data management for a given domain of expertise (Research, Development, Supply Chain, etc.). Manage a team of Data Governance Specialists and Data Stewards for a specific domain. Responsible for operationalizing the Enterprise data governance framework and aligning broader collaborator community with their data governance needs, including data quality, data access controls, compliance with privacy and security regulations, foundational master data management, data sharing, communication and change management. Works with Enterprise MDM and Reference Data to enforce standards and data reusability. Drives multi-functional alignment in their domain(s) of expertise to ensure adherence to Data Governance principles. Provides expert guidance on business process and system design to support data governance and data/information modelling objectives. Maintain documentation and act as an expert on data definitions, data standards, data flows, legacy data structures / hierarchies, common data models, data harmonization etc. for assigned domains. Ensure compliance with data privacy, security, and regulatory policies for the assigned domains Publish metrics to measure effectiveness and drive adoption of Data Governance policy and standards, that will be applied to mitigate identified risks across the data lifecycle (e.g., capture / production, aggregation / processing, reporting / consumption). Establish enterprise level standards on the nomenclature, content, and structure of information (structured and unstructured data), metadata, glossaries, and taxonomies. Jointly with Technology teams, business functions, and enterprise teams (e.g., MDM, Enterprise Data Fabric, etc.) define the specifications shaping the development and implementation of data foundations. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 8 to 10 years of Information Systems experience OR Bachelor s degree and 10 to 14 years of Information Systems experience, OR Diploma and 14 to 18 years of Information Systems experience 4 years of managerial experience directly managing people and leadership experience leading teams, projects, or programs. Technical skills with in-depth knowledge of Pharma processes with preferred specialization in a domain (e.g., Research, Clinical Trials, Commercial, etc.). Aware of industry trends and priorities and can apply to governance and policies. In-depth knowledge and experience with data governance principles and technology; can design and implement Data Governance operating models to drive Amgen s transformation to be a data driven organization. In-depth knowledge of data management, common data models, metadata management, data quality, master data management, data stewardship, data protection, etc. Experience with data products development life cycle, including the enablement of data dictionaries, business glossary to increase data products reusability and data literacy. Preferred Qualifications: Co-develop the data foundations and data products in collaboration with functions and Digital teams. Ability to successfully implement complex projects in a fast-paced environment and in managing multiple priorities effectively. Ability to manage projects or departmental budgets. Experience with modelling tools (e.g., Visio). Basic programming skills, experience in data visualization and data modeling tools. Experience working with agile development methodologies such as Scaled Agile. Soft Skills: Ability to build business relationships and understand end-to-end data use and needs. Excellent interpersonal skills (team player). People management skills either in matrix or direct line function. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals Good presentation and public speaking skills. Good attention to detail, quality, time management and customer focus. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Posted 2 weeks ago
5.0 - 9.0 years
7 - 11 Lacs
Hyderabad
Work from Office
Let s do this. Let s change the world. In this vital role you will coach who facilitates team with Scrum events, processes, and supports teams in delivering value for Veeva Vault Team. The role involves facilitating communication and collaboration among teams, ensuring alignment with the program vision, handling risks and dependencies, and driving relentless improvement. The Scrum master help adapt SAFe to the organization s needs, standardizing and documenting practices. The role requires a solid background in the end-to-end software development lifecycle and a Scaled Agile practitioner, coupled with leadership and transformation experience. Roles & Responsibilities: Lead and handle product delivery using agile frameworks and techniques. Align with Agile values such as prioritizing individuals and interactions over processes and tools for Veeva Vault systems Team. Capture the voice of the customer to define business processes and product needs Collaborate with business stakeholders, Architects and Engineering teams to prioritize release scopes and refine the Product backlog Lead and facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team Clearly express features in User Stories/requirements so all team members and stakeholders understand how they fit into the product backlog Ensure Acceptance Criteria and Definition of Done are well-defined Advise SAFe events, including PI Planning, Scrum of Scrums, and Inspect & Adapt workshops. Stay focused on software development to ensure it meets requirements, providing proactive feedback to stakeholders Help develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and achievements Identify and manage risks associated with the systems, requirement validation, and user acceptance Develop & maintain documentations of configurations, processes, changes, communication plans and training plans for end users Collaborate with geographically dispersed teams, including those in the US and other international locations. Develop a culture of collaboration, innovation, and continuous improvement What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is with these qualifications. Basic Qualifications: Masters degree / Bachelors degree and 5 to 9 years in Software Development OR IT Development OR Related Field Preferred Qualifications: Must-Have Skills: 6-8 years of experience working in global pharmaceutical Industry Solid understanding of GxP regulations, specifically 21 CFR Part 11. Expertise in defining and implementing validation strategies aligned with regulatory requirements. Experience in creating and driving validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)). Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity. Familiarity with GxP Validation management tools such as ALM, Veeva Validation Manager Vault etc. Good-to-Have Skills: Proficiency in automation tools and validation software. Experience of DevOps, Continuous Integration and Continuous Delivery methodologies. Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies (Scrum Agile etc.). Professional Certifications: SAFe for Teams (Must Have) Veeva Vault Platform Administrator (preferred) Soft Skills: Able to work under minimal supervision. Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work. Excellent analytical and gap/fit assessment skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills. Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Posted 2 weeks ago
8.0 - 13.0 years
20 - 25 Lacs
Hyderabad
Work from Office
Let s do this. Let s change the world. In this vital role you will require expertise in biopharma scientific domains as well as compute systems solution delivery. Collaborate with geographically dispersed teams, including those in the US, EU and other international locations. Partner and ensure alignment of the Amgen India DTI site leadership and follow global standards and practices. Provide domain expertise for Research Advanced Scientific Computing within a Scaled Agile Framework (SAFe) product team Serve as Agile team scrum master or project manager as needed Serve as a liaison between Global Technology functional areas and Global Research scientists, prioritizing their needs and expectations Create functional analytics dashboards and fit-for-purposes applications for progress tracking and performance measurements (e.g. PowerBI, Tableau, Spotfire) Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Translate complex scientific and technological needs into clear, actionable requirements for development teams Develop and maintain release deliverables that clearly outlines the planned features and enhancements, timelines, and milestones Identify and manage risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific compute systems operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The ideal candidate will have a strong background in the end-to-end infrastructure DevOps lifecycle and be a Scaled Agile practitioner, coupled with change management and transformation experience. This role demands the ability to deliver against key organizational strategic initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Basic Qualifications: Doctorate degree / Masters degree / Bachelors degree with 8 to 13 years of experience in Information Systems Preferred Qualifications: BS, MS or PhD in Bioinformatics, Computational Biology, Computational Chemistry, Life Sciences, Computer Science or Engineering 3+ years of experience in implementing and supporting biopharma scientific computing environments or systems Functional Skills: Must-Have Skills: Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology and data Excellent communication skills and experience creating impactful slide decks with data Collaborative spirit and effective communication skills to work seamlessly in a cross-functional team Familiarity with scientific compute applications like cheminformatics, bioinformatics, structural biology and molecular modelling tools including Schrodinger, Cryosparc, GROMACS Good-to-Have Skills: Demonstrated expertise in a scientific domain area and related technology needs Familiarity with documentations, specifications, pricing estimates for cloud (e.g. AWS) and on-premise compute infrastructure including compute (e.g. EC2) and storage (e.g. S3) components Familiarity with advanced analytics, AI/ML and scientific computing infrastructure, such as High Performance Compute (HPC) environments and clusters (e.g SLURM, Kubernetes) Experience with scientific and technical team collaborations, ensuring seamless coordination across teams and driving the successful delivery of technical projects Ability to deliver features meeting research user demands using Agile methodology An ongoing commitment to learning and staying at the forefront of AI/ML advancements. We understand that to successfully sustain and grow as a global enterprise and deliver for patients we must ensure a diverse and inclusive work environment. Professional Certifications (please mention if the certification is preferred or mandatory for the role): SAFe for Teams certification (preferred) SAFe Scrum Master or similar (preferred) Soft Skills: Strong transformation and change management experience. Exceptional collaboration and communication skills. High degree of initiative, self-motivation and learning agility Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Posted 2 weeks ago
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